MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.157S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information is unknown.Date of device breakage is an unknown date between (b)(6) 2018 and (b)(6) 2018.Lot number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unavailable.Reporter is a synthes sales consultant.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent a revision surgery due to a broken trochanteric femoral nail-advance (tfna) nail.The patient was originally implanted with the tfna nail on (b)(6) 2018 to treat a reverse oblique intertrochanteric / subtrochanteric fracture.On (b)(6) 2018, an x-ray showed an intact nail but on (b)(6) 2018 the nail was broken as revealed on the x-ray.The tfna proximal nail was broken just above the helical blade.There was no malfunction of the blade or distal locking screw.The surgery was successfully completed with no surgical delay.Current patient status is unknown.Concomitant device: tfna helical blade (part: unknown, lot: unknown, quantity: 1); distal locking screw (part: unknown, lot: unknown, quantity: 1).This report is for a 11 mm/130 degree titanium (ti) cannulated tfna 360 mm/left ¿ sterile.This is report 1 of 1 for (b)(4).
Event or Problem Description
It is unknown if a new device was implanted.Concomitant device: tfna 85mm helical blade (part: unknown, lot: unknown, quantity: 1); 85mm distal locking screw (part: unknown, lot: unknown, quantity: 1).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional information provided.Concomitant devices updated.Body mass index (bmi) reported as 44.92.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: customer quality conducted an investigation of the returned device.Flow: broken visual inspection: the tfna nail (part # 04.037.157s, lot # unknown, mfg date unknown) was received at us cq with the proximal head of the nail broken.The nail broke in two pieces at the helical blade insertion hole, the top of the femoral head was completely broken off and not returned to us cq.No x-rays were sent to us cq.Dimensional inspection: dimensional analysis was completed, the outer diameter of the distal femoral head measured 15.67 mm and the inner diameter measured 9.99 mm this is within the specifications of 15.66 mm ± 0.1 and 10 mm ± 0.05 respectively, based on drawing.Document/specification review: the following drawing(s) was reviewed; ti cannulated trochanteric femoral nail ¿ advanced: a dhr review and material review could not be performed as the lot number is unknown.Conclusion: the complaint condition is confirmed as the tfna nail (part # 04.037.157s, lot # unknown) was received broken.Based on the available information it is not possible to determine a definitive root cause for the complaint condition.Lack of patient compliance, improper placement/locking of the nail, patient co-morbidities, amongst other factors could have contributed to the complaint condition, but there is no indication that the design and manufacture of the nail contributed to the complaint condition.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.This complaint condition is adequately covered by the risk assessment.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 11MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7721765
• Report Number: 2939274-2018-53084
• Device Sequence Number: 732015
• Product Code: HSB
• UDI-Device Identifier: 10886982096654
• UDI-Public: (01)10886982096654
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.157S
• Device Catalogue Number: 04.037.157S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 09/04/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 08/20/2018; 09/06/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2018.; SEE DESCRIPTION, THERAPY DATE: (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR